Owlstone Medical’s mission is to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease.

As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. 

We are therefore looking for a QA Officer to join the QA team and support the business with the compliance of our QMS – Currently ISO9001:2015 and 21CFR Part 820. The vision is also to certify to ISO13485 in 2025.

Key Tasks and Accountabilities

• Work with the Program/Project Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint
• Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes by way of conducting internal audits.
• Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule.
• Provide support with desk-based, remote and on-site audits of sub-contractors and suppliers.
• Working with other QA staff, provide support to departments, e.g. reporting on Quality Metrics as well as assisting in training of personnel on matters relating to the QMS and Induction of new starters on Quality aspects.
• Support Quality department initiatives as required, as part of a multi-disciplinary team

Working Arrangement: This is an onsite role based at our main offices on the Cambridge Science Park four days per week, with the ability to work from home one day per week, this day is a flexible day to meet the needs of the role and team.

Requirements

Competencies & Requirements for the role:

Essential

• Planning and Organising
• Demonstrable evidence of the tasks outlined above
• Experience in writing quality procedures
• Strong presentation, communication and influencing skills
• Pragmatic with a flexible approach and the ability to deal with changing priorities
• Ability to work in a dynamic environment

Education and Training

• Degree level qualification within Life Sciences (or equivalent)
• Trained and competent lead auditor (internal audits)

Experience / Knowledge

• Suitable working knowledge within a Pharmaceutical/Medical Device QA department
• Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards
• Essential: ISO 9001, ISO 13485, GCP,
• Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits)
• Experience of an Electronic Document Management System

Skills:

• Good inter-personal and communication skills
• Good organisational and time management skills

Benefits

About Owlstone Medical

Owlstone Medical is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using

Owlstone is an equal opportunity employer, and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and the attainment of a Baseline Personnel Security Standard (BPSS) check. Access to selected project information requires prior additional security authorization. Access to US technical data by employees requires prior Export Control function approval. Full clearance must be satisfactorily attained against all applicable project security and US export control authorisations. Failure to meet any reference, BPSS, project-security or export-control authorisations may have an impact on successfully completing your probationary period.

Notice to agencies

Owlstone Medical Ltd politely requests no contact from recruitment agencies or media sales. We don’t accept speculative CVs from recruitment agencies nor accept the fees associated with them.